Acetylcysteine ​​instructions for use effervescent tablets 200. Release form, composition and packaging. Release form Vicks Active ExpectoMed

Instruction
on the use of a medicinal product for medical use

Registration number:

P N015473/01-180914

Trade name of the drug:

International non-proprietary name:

Dosage form:

Compound:

1 effervescent tablet contains:
active substance: acetylcysteine ​​- 200.00 mg; Excipients: anhydrous citric acid - 558.50 mg; sodium bicarbonate - 200.00 mg; sodium carbonate anhydrous - 100.00 mg; mannitol - 60.00 mg; anhydrous lactose - 70.00 mg; ascorbic acid - 25.00 mg; sodium saccharinate - 6.00 mg; sodium citrate - 0.50 mg; blackberry flavor "B" - 20.00 mg.

Description: white, round, flat-cylindrical tablets with a score on one side, with a blackberry odor. There may be a slight sulfur odor.
Reconstituted Solution: colorless transparent solution with a smell of blackberry. There may be a slight sulfur odor.

ATX code: R05CB01.

Pharmacological properties

Indications for use

Contraindications:

Carefully: history of gastric and duodenal ulcer, bronchial asthma, obstructive bronchitis, hepatic and / or renal failure, histamine intolerance (long-term use of the drug should be avoided, because acetylcysteine ​​affects histamine metabolism and can lead to signs of intolerance, such as headache, vasomotor rhinitis, itching), esophageal varicose veins, adrenal diseases, arterial hypertension.

Use during pregnancy and during breastfeeding

Dosage and administration

Inside, after eating.
Effervescent tablets should be dissolved in one glass of water. Tablets should be taken immediately after dissolution, in exceptional cases, you can leave the solution ready for use for 2 hours. Additional fluid intake enhances the mucolytic effect of the drug. With short-term colds, the duration of administration is 5-7 days. In chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to achieve a preventive effect against infections.
In the absence of other prescriptions, it is recommended to adhere to the following dosages:
Mucolytic therapy:
adults and children over 14 years of age: 1 effervescent tablet 2-3 times a day (400-600 mg);
children from 6 to 14 years old: 1 effervescent tablet 2 times a day (400 mg);
children from 2 to 6 years old: 1/2 effervescent tablet 2-3 times a day (200-300 mg).
Cystic fibrosis:
children from 2 to 6 years old: 1/2 effervescent tablet 4 times a day (400 mg);
children over 6 years old: 1 effervescent tablet 3 times a day (600 mg).

Side effect

According to the World Health Organization (WHO), adverse effects are classified according to their frequency of development as follows: very often (≥ 1/10), often (≥1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10000, <1/1000) и очень редко (<1/10000); частота неизвестна (частоту возникновения явлений нельзя определить на основании имеющихся данных).
allergic reactions
infrequently: skin itching, rash, exanthema, urticaria, angioedema, lowering blood pressure, tachycardia;
very rarely: anaphylactic reactions up to anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
From the respiratory system
rarely: shortness of breath, bronchospasm (mainly in patients with bronchial hyperreactivity in bronchial asthma).
From the gastrointestinal tract
infrequently: stomatitis, abdominal pain, nausea, vomiting, diarrhea, heartburn, dyspepsia.
Sensory disturbances
infrequently: noise in ears.
Other
infrequently: headache, fever, isolated reports of bleeding due to hypersensitivity reactions, decreased platelet aggregation.

Overdose

Interaction with other drugs

With the simultaneous use of acetylcysteine ​​​​and antitussives due to the suppression of the cough reflex, sputum stagnation may occur.
When used simultaneously with antibiotics for oral administration (penicillins, tetracyclines, cephalosporins, etc.), their interaction with the thiol group of acetylcysteine ​​is possible, which can lead to a decrease in their antibacterial activity. Therefore, the interval between taking antibiotics and acetylcysteine ​​should be at least 2 hours (except for cefixime and loracarbene).
Simultaneous use with vasodilators And nitroglycerin may lead to an increase in vasodilator action.

special instructions

Influence on the ability to drive vehicles, mechanisms

There are no data on the negative effect of the drug ACC ® 200 in recommended doses on the ability to drive vehicles, mechanisms.

Special precautions for the disposal of unused medicinal product

There is no need for special precautions when discarding unused ACC 200.
Close the tube tightly after taking the pill!

Release form

Storage conditions

In a dry place at a temperature not exceeding 25°C.
Keep out of the reach of children.

Best before date

3 years.
Do not use after the expiration date.

Holiday conditions

Manufacturer

1 sachet contains 3 g of powder

active substance: acetylcysteine ​​200 mg

excipients: sucrose, ascorbic acid, saccharin, dry orange flavor 1:1000 Sotteri 289**

(**- Orange flavor essence 11.1%, dextrose anhydride 82.7%, lactose 6.2%)

Description

Powder from white to yellowish color, with partial agglomeration of particles, with an orange smell.

The reconstituted solution is colorless, clear or slightly opalescent.

Pharmacotherapeutic group

Preparations for the treatment of diseases of the respiratory system. Medicines to relieve the symptoms of colds and coughs. Expectorants. Mucolytics. Acetylcysteine

ATX code R05 CB01

Pharmacological properties

Pharmacokinetics

Following oral administration, acetylcysteine ​​is rapidly absorbed from the gastrointestinal tract (GIT) and metabolized in the liver to cysteine, the pharmacologically active metabolite, as well as to diacetylcysteine, cystine, and various mixed disulfides.

Due to the high first pass effect through the liver, the bioavailability of acetylcysteine ​​is very low (approximately 10%).

In humans, maximum plasma concentrations are reached after 1-3 hours. The maximum plasma concentration of the cysteine ​​metabolite is about 2 µmol/l. The binding of acetylcysteine ​​to plasma protein is approximately 50%.

Acetylcysteine ​​is excreted through the kidneys almost exclusively in the form of inactive metabolites (inorganic sulfates, diacetylcysteine).

The plasma half-life is approximately 1 hour and is mainly determined by hepatic biotransformation. Therefore, impaired liver function leads to a prolongation of the plasma elimination half-life up to 8 hours.

Pharmacodynamics

Acetylcysteine ​​is a derivative of the amino acid cysteine. Acetylcysteine ​​has secretolytic and secretomotor action in the respiratory tract. It breaks disulfide bonds between mucopolysaccharide chains and has a depolymerizing effect on DNA chains (with purulent sputum). Due to these mechanisms, the viscosity of sputum decreases.

An alternative mechanism of acetylcysteine ​​is based on the ability of its reactive sulfhydryl group to bind chemical radicals and thereby render them harmless.

Acetylcysteine ​​increases the synthesis of glutathione, which is important for the detoxification of toxic substances. This explains its antidote effect in paracetamol poisoning.

When used prophylactically, it has a protective effect on the frequency and severity of exacerbations of bacterial infections, which has been found in patients with chronic bronchitis and cystic fibrosis.

Indications for use

Secretolytic therapy for acute and chronic diseases of the bronchi and lungs, accompanied by a violation of the formation and excretion of sputum.

Method of application and dosage

ACC® 200 is taken only in the form of a prepared solution, after meals.

Adults and teenagers aged 14 and over

1 sachet of powder 2-3 times a day (corresponds to 400-600 mg of acetylcysteine ​​per day).

Children and teenagers from 6 to 14 years old

1 sachet of powder 2 times a day (corresponds to 400 mg of acetylcysteine ​​per day).

The duration of treatment depends on the type and severity of the disease and should be determined by the attending physician.

Solution preparation:

The powder dissolves in a glass of boiled water and is taken after meals.

Side effects

Not often (≥1/1000,<1/100)

Allergic reactions (itching, urticaria, skin rash, bronchospasm, angioedema, exanthema)

Tachycardia

Arterial hypotension

Headache

Fever

Stomatitis, abdominal pain, diarrhea, vomiting, heartburn, nausea

Noise in ears

Rarely (≥1/10000,<1/1000)

Shortness of breath, bronchospasm mainly in patients with increased reactivity of the bronchial system associated with bronchial asthma

Dyspepsia

Very rarely (< 1/10 000)

Bleeding and hemorrhage associated in part with hypersensitivity reactions

Anaphylactic reactions, up to anaphylactic shock

Stevens-Johnson syndrome, Lyell's syndrome

unknown

swelling of the face

In various studies, a decrease in platelet aggregation under the action of acetylcysteine ​​has been proven. At present, the clinical significance of this phenomenon has not been established.

Contraindications

Hypersensitivity to any component of the drug

Peptic ulcer of the stomach and duodenum in the acute stage

Hemoptysis, pulmonary hemorrhage

Bronchial asthma in the acute stage

Phenylketonuria

Children's age up to 6 years

Fructose intolerance, galactose intolerance, deficiency of saccharin-isomaltose, lactose, glucose-galactose malabsorption syndrome

With caution: varicose veins of the esophagus, bronchial asthma, diseases of the adrenal glands, liver and / or kidney failure, arterial hypertension.

Drug Interactions

The simultaneous use of acetylcysteine ​​and antitussives can cause dangerous secretory stasis due to a decrease in the cough reflex. For this reason, this combination therapy option should be based on a particularly accurate diagnosis.

To achieve the best therapeutic effect, oral antibiotics (penicillins, tetracyclines and aminoglycosides) should be administered separately, with a two-hour time interval. This does not apply to cefixime and loracarbef.

The use of activated charcoal in large doses can weaken the effect of acetylcysteine.

The simultaneous use of nitroglycerin and acetylcysteine ​​should be carried out under the supervision of a physician, since it is possible to increase the vasodilating effect and the inhibitory effect on platelet aggregation.

Acetylcysteine ​​may interfere with the colorimetric quantitation of salicylates.

Acetylcysteine ​​may interfere with urinalysis for ketone bodies.

special instructions

In the event of changes in the skin and mucous membranes, the patient should immediately stop taking acetylcysteine ​​and consult a doctor.

Patients with bronchial asthma and obstructive bronchitis ACC® 200 should be administered with caution under the systematic monitoring of bronchial conduction due to the risk of bronchospasm.

The use of the drug ACC® 200 can lead to liquefaction of sputum in the bronchi and some increase in its volume. With insufficient cough reflex applied: postural drainage or aspiration.

Patients with histamine intolerance should take ACC® 200 in short courses, due to the influence on the metabolism of histamine itself, the possible appearance of symptoms of intolerance (for example, headache, runny nose, itching).

Active substance

Acetylcysteine*(Acetylcysteinum)

ATH:

Pharmacological group

Nosological classification (ICD-10)

Compound

ACC ® Long

Description of the dosage form

Effervescent tablets, 100 mg, 200 mg: white, round, flat tablets, scored (200 mg), with a blackberry odor.

Effervescent tablets, 600 mg: white, round tablets, beveled, notched on one side, smooth surface, blackberry odour.

Appearance of the solution: when dissolving 1 table. in 100 ml of water a colorless transparent solution with a blackberry odor is obtained.

pharmachologic effect

pharmachologic effect- mucolytic .

Pharmacodynamics

The presence of sulfhydryl groups in the structure of acetylcysteine ​​contributes to the breaking of disulfide bonds of sputum acid mucopolysaccharides, which leads to a decrease in the viscosity of mucus. It has a mucolytic effect, facilitates sputum discharge due to a direct effect on the rheological properties of sputum. The drug remains active in the presence of purulent sputum.

With the prophylactic use of acetylcysteine, there is a decrease in the frequency and severity of exacerbations in patients with chronic bronchitis and cystic fibrosis.

Indications of the drug

Respiratory diseases, accompanied by the formation of viscous sputum difficult to separate:

acute and chronic bronchitis;

obstructive bronchitis;

laryngotracheitis;

pneumonia;

bronchiectasis;

bronchial asthma;

bronchiolitis;

cystic fibrosis;

acute and chronic sinusitis;

inflammation of the middle ear (otitis media).

Contraindications

Common for all dosage forms (effervescent tablets 100, 200, 600 mg)

hypersensitivity to acetylcysteine ​​or other components of the drug;

pregnancy;

lactation.

Additionally for effervescent tablets 100, 200 mg:

peptic ulcer of the stomach and duodenum in the acute stage;

hemoptysis;

pulmonary hemorrhage.

Carefully: varicose veins of the esophagus, bronchial asthma, diseases of the adrenal glands, liver and / or kidney failure.

Additionally for 600 mg effervescent tablets:

children's age (up to 14 years).

Carefully: peptic ulcer of the stomach and duodenum in the acute stage; hemoptysis, pulmonary bleeding, varicose veins of the esophagus, bronchial asthma, adrenal disease, liver and / or kidney failure.

Use during pregnancy and lactation

For all dosage forms.

To ensure safety, due to insufficient data, prescribing the drug during pregnancy and lactation is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Side effects

In rare cases, headache, inflammation of the oral mucosa (stomatitis) and tinnitus are observed. Very rarely - diarrhea, vomiting, heartburn and nausea, lowering blood pressure, increased heart rate (tachycardia). In isolated cases, allergic reactions are observed, such as bronchospasm (mainly in patients with bronchial hyperreactivity), skin rash, itching and urticaria. In addition, there are isolated reports of the development of bleeding due to the presence of hypersensitivity reactions.

With the development of side effects, you should stop taking the drug and consult a doctor.

Interaction

With the simultaneous use of acetylcysteine ​​and antitussives, due to the suppression of the cough reflex, mucus stagnation may occur. Therefore, such combinations should be chosen with caution. Synergism of action of acetylcysteine ​​with bronchodilators is noted.

Simultaneous administration of acetylcysteine ​​and nitroglycerin can lead to an increase in the vasodilating effect of the latter.

Pharmaceutically incompatible with antibiotics (penicillins, cephalosporins, erythromycin, tetracycline and amphotericin B) and proteolytic enzymes.

Upon contact with metals, rubber, sulfides are formed with a characteristic odor.

Reduces the absorption of penicillins, cephalosporins, tetracyclines (they should be taken no earlier than 2 hours after ingestion of acetylcysteine).

Dosage and administration

Effervescent tablets 100 and 200 mg

Adults and adolescents over the age of 14: 2 tablets. 100 mg 2-3 times a day or 1 tab. 200 mg 2-3 times a day (400-600 mg of acetylcysteine ​​per day).

Children aged 6 to 14 years: 1 tab. 100 mg 3 times a day or 2 tablets. 2 times a day, or 1/2 tab. (200 mg) 3 times a day, or 1 tab. 200 mg 2 times a day (300-400 mg of acetylcysteine ​​per day).

Children aged 2 to 5 years: 1 tab. 100 mg 2-3 times a day or 1/2 tab. 200 mg 2-3 times a day (200-300 mg of acetylcysteine ​​per day).

Cystic fibrosis.

For patients with cystic fibrosis and weighing more than 30 kg, if necessary, it is possible to increase the dose to 800 mg of acetylcysteine ​​per day.

Children over 6 years of age it is recommended to take 2 effervescent tablets 100 mg 3 times a day or 1 tab. 200 mg 3 times a day (600 mg acetylcysteine ​​per day).

Children aged 2 to 6 years- 1 tab. 100 mg or 1/2 tab. 200 mg 4 times a day (400 mg acetylcysteine ​​per day).

Additional fluid intake enhances the mucolytic effect of the drug. With short-term colds, the duration of administration is 5-7 days. In chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to achieve a preventive effect against infections.

1 effervescent tablet 100 mg corresponds to 0.006 XE, 1 effervescent tablet. 200 mg corresponds to 0.006 XE.

ACC ® Long

The tablets are effervescent.

inside. In the absence of other prescriptions, it is recommended to adhere to the following dosages.

Adults and teenagers over 14 years old it is recommended to take 1 tablet once a day. ACC ® Long (600 mg of acetylcysteine ​​per day).

Effervescent tablets should be dissolved in one glass of water and taken after meals. Tablets should be taken immediately after dissolution, in exceptional cases, you can leave the solution ready for use for 2 hours.

Additional fluid intake enhances the mucolytic effect of the drug.

With short-term colds, the duration of admission is 5-7 days. In case of long-term diseases, the duration of therapy is determined by the attending physician. In chronic bronchitis, the drug should be taken for a longer time to achieve a preventive effect in infections.

Note for diabetic patients:

1 effervescent tablet corresponds to 0.01 XE.

Overdose

With an erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, stomach pain, heartburn and nausea are observed. So far, no severe and life-threatening side effects have been observed.

special instructions

Patients with bronchial asthma and obstructive bronchitis should be prescribed acetylcysteine ​​with caution under the systematic control of bronchial patency.

When treating patients with diabetes, it must be taken into account that effervescent tablets contain sucrose.

When working with the drug, it is necessary to use glassware, avoid contact with metals, rubber, oxygen, easily oxidized substances.

ACC is a drug with an expectorant and mucolytic effect, which contributes to the thinning and discharge of viscous sputum.

This is one of the most famous medicines used in the treatment of diseases of the respiratory tract, accompanied by the formation of a hard-to-separate secret.

On this page you will find all the information about ACC: full instructions for use for this drug, average prices in pharmacies, complete and incomplete analogues of the drug, as well as reviews of people who have already used ACC tablets. Want to leave your opinion? Please write in the comments.

Clinical and pharmacological group

mucolytic drug.

Terms of dispensing from pharmacies

Released without a prescription.

Prices

How much do ACC effervescent tablets cost? The average price in pharmacies is at the level of 200-300 rubles.

Release form and composition

The drug is produced in different dosage forms:

• ACC 100 mg (effervescent tablets);
• ACC 200 mg (effervescent tablets);
• ACC 600mg (effervescent tablets);
• ACC granules for making syrup;
• Powder for solution preparation;
• ACC syrup.

They are produced with different concentrations of the active substance - they contain 100, 200 and 600 mg of the active substance acetylcysteine ​​+ auxiliary components. ACC 100mg tablets are intended for children, and the drug with the highest concentration of acetylcysteine ​​(600 mg) is called ACC Long and is prescribed for adult patients and adolescents over 14 years of age.

Pharmacological effect

The mucolytic effect of the drug is provided by the active substance acetylcysteine, which is a derivative of cysteine ​​(amino acids). The acetylcysteine ​​molecule has sulfhydryl groups in its structure, which contributes to the disruption of the disulfide bonds of mucopolysaccharides in the sputum, which provide the viscosity of the secret. As a result, sputum softens and is easier to separate from the walls of the bronchi.

The drug has a direct effect on the density and rheological properties of sputum, maintaining proper activity even with purulent impurities in the bronchial secret. With the prophylactic use of acetylcysteine, patients with cystic fibrosis and chronic bronchitis note a decrease in the number and severity of exacerbations.

Another effect of acetylcysteine ​​is an antioxidant pneumoprotective effect, which is realized by binding and neutralizing chemical radicals by sulfhydryl groups. The drug accelerates the synthesis of glutathione, an intracellular protection factor against a number of cytotoxic substances and oxidative toxins of internal and external origin, which allows the use of ACC in paracetamol overdose.

Indications for use

• (inflammation of the mucous membrane of the larynx);
• (inflammation of the mucous membrane of the trachea);
• (spicy, );
• bronchiectasis (chronic suppurative process in irreversibly deformed bronchi);
• bronchiolitis (inflammation of the bronchioles);
• middle exudative (damage to the mucous membranes of the middle ear cavities);
• (inflammation of one or more paranasal sinuses);
• cystic fibrosis (severe dysfunction of the respiratory and gastrointestinal tract).

Contraindications

Contraindications to the use of ACC are as follows:

• pulmonary bleeding;
• pregnancy;
• peptic ulcer of the stomach and duodenum in the acute phase;
• hemoptysis;
• lactation period (breastfeeding);
• children under 14 years of age (dosage forms of the drug containing 600 mg of acetylcysteine);
• children under 6 years of age (preparation in the form of granules for the preparation of a solution for oral administration of 200 mg);
• hypersensitivity to acetylcysteine ​​and other components of the drug.

WITH caution the drug should be used in patients with varicose veins of the esophagus, with an increased risk of developing pulmonary hemorrhage and hemoptysis, with bronchial asthma, diseases of the adrenal glands, liver and / or kidney failure.

ACC LONG should not be administered to children under 14 years of age. In this category of patients, it is recommended to use dosage forms of the drug for oral administration with a lower content of acetylcysteine.

Use during pregnancy and lactation

There is no embryotoxic effect in acetylcysteine, however, during pregnancy, as well as during breastfeeding, it is prescribed only if there are indications under the supervision of a physician.

Instructions for use

The instructions for use indicate that ACC effervescent tablets are taken orally after meals. They should be dissolved in 1 glass of water and drunk immediately, in exceptional cases, you can leave the finished solution for 2 hours. Additional fluid intake enhances the mucolytic effect of the drug.

With short-term colds, the duration of admission is 5-7 days. In chronic bronchitis and cystic fibrosis, the drug should be used for a longer time to prevent infections.

Instructions for ACC 200:

1. Children aged 6 to 14 years are recommended to take 1 tab. (ACC 200) 2 times / day, which corresponds to 400 mg of acetylcysteine ​​per day.
2. For children aged 2 to 6 years, the drug is recommended to take 1/2 tab. (ACC 200) 2-3 times / day, which corresponds to 200-300 mg of acetylcysteine ​​per day.
3. Adults and adolescents over 14 years of age are recommended to prescribe the drug 200 mg (ACC 200) 2-3 times / day, which corresponds to 400-600 mg of acetylcysteine ​​per day, or 600 mg (ACC Long) 1 time / day.
4. In cystic fibrosis, children over the age of 6 years are recommended to take the drug 1 tab. (ACC 200) 3 times / day, which corresponds to 600 mg of acetylcysteine ​​per day. Children aged 2 to 6 years - 1/2 tab. (ACC 200) 4 times / day, which corresponds to 400 mg of acetylcysteine ​​per day.

Side effects

ACC effervescent tablets are generally well tolerated; when taken orally as a solution, a number of side effects may develop, which include:

• From the digestive system - nausea, sometimes vomiting, heartburn, stool disorder in the form of diarrhea (diarrhea).
• Allergic reactions - rarely develop, the severity can be different. Manifested in the form of a rash on the skin, itching, urticaria (rash and swelling of the skin, outwardly resembling a nettle burn). In extremely rare cases, there may be a reaction from the bronchi in the form of their spasm, reminiscent of an attack of bronchial asthma. With a very severe course of an allergic reaction, anaphylactic shock develops with the development of multiple organ failure against the background of a progressive decrease in systemic blood pressure.
• From the side of the cardiovascular system - tachycardia (increased heart rate), arterial hypotension (decrease in systemic blood pressure).
• From the side of the central nervous system - headache, tinnitus,

In case of symptoms of adverse reactions, the use of the drug should be discontinued and medical attention should be sought.

Overdose

Various disorders of the digestive system (stool disorders, nausea, vomiting, heartburn, pain in the stomach).

When the described phenomena occur, drug elimination of symptoms is performed.

special instructions

1. The mucolytic effect of ACC is enhanced by additional fluid intake.
2. Patients with obstructive bronchitis and bronchial asthma require regular monitoring of bronchial patency during treatment with ACC.
3. The drug is incompatible with proteolytic enzymes and antibiotics (with cephalosporins, tetracycline, penicillins, erythromycin and amphotericin B).
4. It should not be combined with antitussive drugs, since the suppression of the cough reflex caused by the latter can lead to dangerous mucus stagnation.
5. With caution, the remedy should be used for violations of the liver and kidneys, diseases of the adrenal glands, varicose veins of the esophagus, as well as peptic ulcer of the stomach and duodenum in the acute phase.

drug interaction

Tetracycline and its derivatives (except doxycycline) should not be used together with ACC in pediatrics.

During experimental in vitro studies, there were no cases of inactivation of other types of antibacterial drugs. However, it is recommended to observe the interval between taking ACC and antibiotic at least 2 hours. In vitro, the incompatibility of acetylcysteine ​​with semi-synthetic penicillins, aminoglycoside and cephalosporin antibiotics has been proven. Such studies have not been conducted with erythromycin, amoxicillin and cefuroxime.

Simultaneous use of antitussive drugs can lead to stagnation of the secretion of the respiratory tract.

The use of nitroglycerin may enhance the vasodilating effect of the latter.